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Archive for August 2018

Science Policy Around the Web – August 31, 2018

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By: Jennifer Patterson-West, Ph.D

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source: defense.gov

Public Health

Record High Number of STD Infections in U.S., As Prevention Funding Declines 

This week at the biennial 2018 National STD Prevention Conference sexual health professionals, including scientists and clinician, discussed new prospects to improve the health of our communities at a time when STD rates are on the rise.

The United States has the highest rate of sexually transmitted diseases (STD) in the industrial world.  Preliminary data indicates that nearly 2.3 million cases of chlamydia, gonorrhea, and syphilis were diagnosed in 2017.  These numbers reflect an increase in gonorrhea cases by 67% and syphilis by 76% over the past 4 years.

The director of the Center of Disease Control (CDC)’s division of STD prevention, Dr. Gail Bolan warns that “we’ve been sliding backwards” in our efforts to control STDs.  A major challenge in mitigating the spread of STDs is that the majority of individuals that carry the disease display no symptoms and remain unaware that they are infected.  For this reason, annual testing for chlamydia and gonorrhea is recommended for sexually active women under the age of 25 and males with male partners.  Patients are strongly encouraged to request STD testing because not all doctors will habitually offer these tests.

David Harvey, executive director of the National Coalition of STD directors, notes that congenital transmission of syphilis is diagnosed in a thousand babies annually despite the virtual eradication of HIV transmission from mother to child.   The continued occurrence of congenital syphilis, which can cause birth defects or result in stillbirth, is shocking due to the fact that syphilis can be effectively treated by antibiotics if caught early.

David Harvey emphasizes that a key factor in this growing health crisis is a roughly 40 percent drop in funding for the prevention and control of STDs over the past 15 years.  Taking into account that more than 50 percent of all Americans will contract an STD in their lifetime, the prevalence of STDs in the U.S. is a health crisis that needs to be addressed before our current methods of treatment are no longer effective. For instance, 4 percent of Neisseria gonorrhoeae patient samples are now resistant to antibiotic treatment. This Illustrates the need for new treatment options and the increased engagement with the public to encourage testing and the use of preventative measures.

(Richard Harris, NPR)

The Environment

Will More Logging Save Western Forests from Wildfires? 

According to the National Interagency Fire Center there have already been 38,832 wildfires this year.  Approximately 90 percent of these are human-caused due to negligence or intentional acts.

Given suitable environmental conditions, something as inane as the sparks from a flat tire has the potential to cause a catastrophe.  These circumstances are what caused the Carr Fire in Redding, California that burned over 200,000 and destroyed more than a thousand homes.

Recent disasters have people looking for preventative measures to minimize the occurrence and spread of wildfires.  In response, the Trump administration is promoting the expansion of logging in western states.  The administration emphasizes that environmental regulations are magnifying this issue.  Senator Steve Daines (R-Mont.) proposed a bill, Protect Collaboration for Healthier Forests Act, to accelerate forest management projects by reducing legal appeals.

However, forest and industrial experts counter that a sustainable solution is actually more involved and expensive then the simple expansion of logging.  Bill Oliver, a retired forest official, stresses that the forests are too dense and that bushes and small diameter trees that fuel mega fires are what need to be cleared. Conversely, it is the larger trees that are coveted by the timber industry and consumers.

However, one of California wood producer’s Sierra Pacific industry is investing in upgrading systems to use smaller diameter wood to produce commercial products, such as particle board. Dan Tomascheski, the vice president of Forest Resources for Sierra Pacific Industries, asserts that industry will need reassurances that use of public lands will not be a short-term initiative.

The Forest service affirms that nationwide there are approximately 80 million acres of forest lands at high risk of major fires with only two million have been treated thus far. Despite the potential benefit of forest management project, Forest management consultant Rich Armstrong emphasizes that budget cuts for wildfire mitigation and other forest programs are the biggest enemy to forest management. A separate fund to pay for wildfire suppression has recently been passed in congress due to bi-partisan efforts and will go into effect next year.

(Kirk Siegler, NPR)

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August 31, 2018 at 5:25 pm

Science Policy Around the Web – August 28, 2018

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By: Patrick Wright, Ph.D

Pills

source: defense.gov

The Opioid Epidemic

Tapered to Zero: In Radical Move, Oregon’s Medicaid Program Weighs Cutting Off Chronic Pain Patients from Opioids

Oregon is considering legislation that would end insurance coverage of opioids for chronic pain patients enrolled in the state’s Medicaid program in an effort to battle the opioid abuse and overdoses. In 2016, 42,000 Americans died from drug overdoses involving opioids. As of 2016, Oregon’s overdose rate was roughly half the national average, with its prescriber rates slightly higher than the country’s as of 2015. Medicaid patient enrollees are prescribed opioids at a disproportionately high rate and are subsequently at a higher risk for overdose than the general public.

“We believe Oregonians in chronic pain deserve safe and effective pain management. And at the same time, we’re concerned about overdose and death, and we believe pain patients have been put at higher risk with regard to overprescribing.” said Dr. Dana Hargunani, Chief Medical Officer of the Oregon Health Authority (OHA). While other states have worked to improve their drug monitoring programs and have limited first-time opioid prescriptions for acute pain at 3,5, or 7 days, none have gone as far as to remove patients who have not exhibited signs of addiction or abuse. Unfortunately, there is currently not enough evidence on either side to know the most effective, safest approach to managing this issue; long-term opioid therapy has both benefits and risks.

The Centers for Disease Control and Prevention (CDC) states there is insufficient evidence to draw any conclusion. Its guidelines state that physicians must weigh managing the original pain symptoms warranting opioid treatment against the symptoms of withdrawal that will occur coincident with treatment cessation if the patient is opioid dependent. Specifically, it says: “Tapering plans should be individualized and should minimize symptoms of opioid withdrawal while maximizing pain treatment with nonpharmacologic therapies and nonopioid medications”. Beginning in 2020, opioid doses for Oregon’s Medicaid patient populations would be tapered to zero over 12 months under the new policy.

The proposed policy is not strictly black-and-white, however. “It is important to note that this policy would not be universal. If doctor/patient felt that the taper was inappropriate because of the specific circumstances and comorbidities for that patient, and exception could be requested and made by the plans,” noted an OHA spokeswoman. There are also disease-specific exclusion criteria, including cancer pain, sickle cell disease, and rheumatoid arthritis. Also, the proposal would include coverage for alternative, non-pharmacological therapies including acupuncture and chiropractic care, despite the evidence for the effectiveness of these approaches as opioid-surrogates being limited.

Many chronic pain patients and Medicaid enrollees in Oregon are protesting the proposal. Laura Dolph, a Medicaid enrollee in Oregon and chronic pain sufferer on an opiate regimen via her physicians, would be directly affected by this policy. Laura has suffered from chronic pain for decades due to porphyria and a back injury from a 1999 car crash. When she previously did not have access to legally prescribed opiates, she turned to illicit drugs. Her daughter, Heather Steinmann, said of her opiate use “When it’s been monitored, she’s been doing great” and her prior issues with illegal drug use were “all because her pain medications were cut off, and she went to street drugs. That’s how I view it. If you don’t have one, then you go to the other.” One of Laura’s previous physicians responsible for prescribing her opiates for pain management said “I was able to taper her down significantly on both [opiates and benzodiazepines] to minimize harm. But I felt like the greater harm would have been if I’d completely taken away her opiates without anything else to give her. I think she probably would have died.” There is also limited scientific evidence outlining the potential positive results of such a plan as a weapon against the opioid epidemic. “What is notably missing is any review of any literature regarding the centerpiece of their proposed policy: Forced opioid taper to zero for all persons” said Dr. Stefan Kertesz, a pain and addiction specialist at the University of Alabama, Birmingham.

Policies such as this proposed by Oregon are a response and consequence to years of over-prescription of opioids for pain management due to inaccurate portrayals of the potential harm of opioids early on. There is an ongoing federal case National Prescription Opiate Litigation (MDL 2804) in the United States District Court of the Northern District Ohio in which hundreds of cities and states are suing manufacturers and distributors, alleging that “manufacturers of prescription opioids grossly misrepresented the risks of long-term use of those drugs for persons with chronic pain, and distributors failed to properly monitor suspicious orders of those prescription drugs—all of which contributed to the current opioid epidemic”.

(Lev Facher, StatNews)

The Opioid Epidemic

In San Francisco, Opioid Addiction Treatment Offered on the Streets

This past May, Mayor Mark Farrell of San Francisco announced a plan to spend $6 million over the next two years on a first-in-the-nation public health program in which city health workers provide homeless people with opioid use disorder with buprenorphine prescriptions which they can fill the same day. This program is partly in response to the increase in the number of people injecting drugs in public spaces in the city. Most of the money will go toward funding 10 physicians as part of the Department of Public Health’s Street Medicine Team. Mayor Farrell emphasized, “The opioid crisis plaguing our country is alive and visible on the streets of San Francisco. The status quo is simply unacceptable. I am creating this program to directly address drug addiction on our streets—to meet these individuals where they are and get them the help they need, and to ensure that our streets remain safe for all our residents”.

This approach is to complement more conventional, clinic-based opioid treatment and outreach methods. A study by Amos Irwin and colleagues included a cost-benefit analysis of potential supervised injection facility (SIF) in San Francisco and found there would be a $2.33 in savings for each dollar spent on a SIF, providing a total annual net saving of $3.5 million for a single 13-booth SIF while reducing the number of total hospital stays and HIV and Hepatitis C cases. Nevertheless, offering these buprenorphine prescriptions in situ, on the streets rather than in a clinic, might help patients bypasses visiting clinics themselves and dealing with appointment scheduling and attendance. The people approached on the streets also tend to be longer-term users compared to those at needle exchange sites, which tend to skew younger and with a shorter history of using. Dr. Barry Zevin, the medical director for Street Medicine and Shelter Health in San Francisco noted, “These vulnerable and complex patients care about their health, but they have suffered from stigma that makes it difficult for them to access the health care system.”

Buprenorphine is the first medication to treat opioid dependency that is permitted for prescription and dispensation outside of a structured clinic. It is a partial opioid agonist approved for clinical use in October 2002 by the Food and Drug Administration. In its capacity as an agonist, it does produce opioid-analogous effects such as euphoria, but in weaker form than that of full opiates. Importantly, however, it helps to lower the potential for misuse, diminishes the effects of physical dependency to opioids such as withdrawal symptoms, and reduces the risk of overdose. It is a form of medication-assisted treatment (MAT) to help users of opiates to reduce or quit.

Thus far, at the end of a yearlong pilot that ended in November 2017, 20 of the 95 participants were still taking buprenorphine under the care of the street medicine team. With the $6 million investment, more than 250 patients will have access to buprenorphine. However, there are an estimated 22,500 active injection drug users in the city as of 2015, half of whom report using heroin. This program is one component of many in the city’s plan to combat the opioid crises. San Francisco Health Director Barbara Garcia stated “Homeless people who use drugs are especially vulnerable, and our system of care needs to adapt. By going directly to them with compassionate outreach and expertise, we are able to help a group that we were missing by relying on a more traditional structure of clinic visits that does not work for everyone.”

(Abby Goodnough, The New York Times)

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August 28, 2018 at 6:02 pm

Science Policy Around the Web – August 24, 2018

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By: Maryam Zaringhalam, PhD

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source: pixabay

Public Health

Doing time on drugs: Jails are slow to dispense meds that curb inmates’ cravings

According to a National Inmate Survey conducted between 2007 and 2009, one in five local jail and state prison inmates across the country have used heroin or opioids, in part because of criminalization of drug use and addiction. In 2010, about 2 million adults were incarcerated in local jails and state prisons. A population of about 400,000 inmates could stand to benefit from opioid interventions. However, only 220 of 3,000 jails nationwide offer naltrexone — a drug that blocks the effects of opioids and can reduce cravings — to inmates. And only about 20 jails offer methadone or buprenorphine — drugs that diminish withdrawal symptoms and reduce cravings.

These medications have been found to increase the likelihood that a person will remain in treatment for drug addiction, which is associated with reduced risk of criminal activities and greater likelihood of employment. Treatment of inmates can also reduce the number of overdose deaths within inmate populations, as well as among people released from jail or prison. Rhode Island has adopted a new program offering its prisoners medication to treat opioid-use disorders. Last year, the number of overdose deaths across Rhode Island plunged by 61 percent among people newly released from jail or prison. In addition, medication can stave off the effects of withdrawal, which is particularly beneficial for opioid users who are newly incarcerated and are forced to quit use cold turkey.

Despite the benefits of medication-assisted treatment, it hasn’t been widely adopted and access remains limited within the criminal justice system. A long-standing belief prevails that abstinence is the cure to overcoming addiction. As a result, medications are stigmatized as a treatment option, despite the body of evidence that points to their efficacy. Methadone and buprenorphine are themselves opioids, though they do not produce the euphoric highs when taken as prescribed, which further reinforces the stigma. In addition, because misuse of these drugs can cause mild opioid-like effects, misuse and illicit sales in jail and prison remains a concern.

Nevertheless, a number of stakeholders in the medical and criminal justice communities, including the American Medical Association, the American Society of Addiction Medicine, and the American Correctional Association, have released statements supporting the use of medications in jail and prison populations.

(Anna Gorman, The Washington Post)

U.S. Policy

Here are 10 topics senators could ask Trump’s science adviser nominee to address

Earlier this month, President Trump nominated meteorologist Kelvin Droegemeier to serve as director of the Office of Science and Technology Policy (OSTP) and act as science adviser to the President. Droegemeier appeared before the Senate on Thursday to begin his confirmation process, which stands to end the longest vacancy in the 42-year history of the OSTP. A well-respected, extreme-weather scientist, Droegemeier stepped down from his post as vice president for research and emeritus professor of meteorology at The University of Oklahoma. His nomination has been largely praised by the scientific community and previously served as vice-chair of the governing board of the U.S. National Science Foundation.

During his confirmation hearing, he is likely to receive questions ranging from concerns around deepening budget cuts to agencies that fund scientific research to concerns around the place of scientific evidence in federal decision making. His position on the role of human activity in climate change will likely also be called into question, particularly in light of comments he made in a 2014 talk at the South Central Climate Center in which he said: “The evidence suggests that [climate change] is human-induced, that is, there’s a strong human signal. But we don’t know everything about the nitrogen cycle, about all the carbon cycling, and about carbon sequestration … I’m very skeptical of people who take that almost deeply ideological position and say we absolutely know the answer. No, we don’t.” He may also face questions regarding the growing movement around combating sexual harassment in STEM fields and the impact of restricting entry of foreign students on research progress in the United States.

OSTP is charged with coordinating federal science policy throughout the executive branch and providing scientific and technological analysis and judgment for the President. Given his track record, Droegemeier is likely to pass through confirmation. Former OSTP Director John Holdren told Science: “I expect he’ll be energetic in defending the R&D budget and climate change research in particular.”

(Jeffrey Mervis, Science)

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August 24, 2018 at 5:55 pm

Science Policy Around the Web – August 16, 2018

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By: Sarah Hawes, Ph.D.

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source: pixabay

Scientific Discoveries

Ambitious ‘Human Cell Atlas’ Aims To Catalog Every Type Of Cell In The Body

You’ve no doubt heard of the Human Genome Project – a 15-year long endeavor to sequence the total human genome, fueled by 3 billion dollars and completed in 2003. But have you heard of the Human Cell Atlas Consortium? MIT biology professor and member of the Broad Institute Aviv Regev has led this collective of hundreds of international scientists since its foundation in 2016.

Just as the intent of the Human Genome Project was to sequence all our genetic material, the intent of the Consortium is to identify every single type of cell in the human body so that they can be investigated and understood independently, and in the complex context of cell-cell interactions, and their role in our physiology. This is a huge endeavor. We currently lack even a rough estimate of how many cell types exist. “People guess anything from the thousands to the tens of thousands. I’m not guessing,” Regev says. “I would rather actually get the measurements done and have a precise answer.”

And how does one delineate cell types in a meaningful way, to take these measurements? This is done by determining which genetic material a cell activates, i.e. which genes it mobilizes from quietly bundled DNA to RNA, and from there into a meaningful protein product to carry out the particular cellular functions defining a heart cell, or a lung cell, or a glial cell in the brain. The technology enabling description of a cells’ genetic character is called single-cell RNA sequencing.

In 2014, Aviv Regev, together with Steve McCarrol, and David Weitz at Harvard, improved on this process to substantially speed it up. “All of a sudden, we moved from something that was very laborious and we could do maybe a few dozen or a few hundred, to something where we could do many, many thousands in a 15- to 20-minute experiment,” Regev says. “We said, ‘That’s at the right scale that we could actually do the human body.’ And this is what they have set out to do.

Today, after just two years and 200 million in NIH funding, the Human Cell Atlas Consortium is beginning to bear fruit.

The first major Human Cell Atlas finding was published this month and simultaneously confirmed by a separate lab at Harvard Medical School. Both papers are published in the journal Nature, and report the definition of a new cell type in the windpipe which is responsible for creating a faulty protein linked to cystic fibrosis. Previously it was believed that the faulty protein originated in common cells lining the windpipe. Discovery of the new and rarer cells, dubbed ‘pulmonary ionocytes,’ will improve scientists’ ability to target faulty protein production by targeting the pulmonary ionocytes, thereby speeding up the development of treatments for cystic fibrosis.

A second consortium-related discovery appeared last week in the journal Science, in which British consortium members published the finding that childhood kidney cancer begins in a cell type which is distinct from the cells giving rise to kidney cancer in adults.

“We knew the lessons from the Human Genome Project were [that] rallying together the entire community would really let you get a full answer to a question. And that full answer will empower everyone to do better and faster and higher-resolution biology,” says Regev. Together, cataloguing all human cell types is predicted to take just another five to ten years. Discoveries building off this catalogue will dramatically enhance medical progress globally, and in perpetuity.

(Karen Weintraub, NPR)

Science and Innovation

It’s ‘Shark Tank’ For Global Health Inventions

A fascinating program to bolster innovation in global health, and particularly for impoverished mothers and children, is coming from a union between government agencies in the US, Norway, Korea, and the UK together with the Bill & Melinda Gates Foundation. This program, called Saving Lives At Birth: A Grand Challenge For Development, hosted a special conference in Washington, D.C. last week to empower global health inventors with the gift of pitch.

Nearly 500 applicants were winnowed down to ten participants, each of which presented global health innovations before a panel of judges rating them not on their science, but on their business plan – including target market, competition and revenue model.

Prior to presenting, each participant worked with consultants to enhance their slides and speeches. Rachele Haber-Thomson, one of the consultants, explained that many participants came from academia or non-profits. She said that while they knew how to write a grant, they needed help to capture the attention of investors looking for compact, business-savvy strategies.

Presentations were compact, seven-minute pitches on practical advances – describing a health problem, a solution, and convincing details on its implementation – all before taking questions from judges on feasibility, marketing, etc. The advances presented included an oxygen concentrator powered by running water, a medicine pouch to prevent transmission of HIV from mother to infant, a new subcutaneous contraceptive, and a system to generate disinfectant from salt and water. The winning pitch came from Gradian Health Systems, and was for a network of mobile medical training centers to enhance quality of care in areas with few physicians.

The prize for a winning pitch was not funding (though the audience included potential backers). Each participant had already been awarded $250,000 to $2 million from Saving Lives At Birth to develop their ideas prior to the conference. Instead of direct funding, the winner was given a choice between competing in a similar sales-pitch show-down in Berlin or else receiving free business-consulting.

As Sofia Stafford of USAID and Saving Lives At Birth puts it, “if these global health projects want to scale up, they need to know how to communicate their vision, grab investors’ interest and attract more funds.” Bearing this in mind, the July conference invokes the proverb “give a man a fish and he’ll eat for a day; teach a man to fish and he’ll eat for a lifetime.” Saving Lives At Birth does both.

(Vicky Hallett, NPR)

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August 16, 2018 at 4:31 pm

Science Policy Around the Web – August 10, 2018

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By: Leopold Kong, PhD

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source: pixabay

The Scientific Workforce

Top US biomedical institute settles gender-discrimination lawsuits

In a joint statement on August 7, 2018, senior cancer researchers Katherine Jones and Victoria Ludblad agreed to drop all charges against the Salk Institute for Biological Studies in La Jolla, California for sexual harassment and gender-based discrimination.  The statement reads: “[…] productive conversations have led to a resolution of all claims between these parties that will enable us to put our disagreements behind us.” However, the settlement does not impact similar allegations against Salk by a third plaintiff, molecular biologist Beverly Emerson, whose contract was not renewed in 2018.  Her lawyer said, “Dr. Emerson intends to proceed until justice is fully achieved.”

All three lawsuits were initiated in July 2017, alleging several discriminatory practices at Salk. These include being excluded from retreats and social events with opportunities to network with donors, being assigned smaller lab spaces than male colleagues, being allocated fewer lab staff than male colleagues, and being paid less than male colleagues. The lawsuits also singled out Salk faculty member Inder Verma, a renowned geneticist who also served as the editor-in-chief of the prestigious research journal Proceedings of the National Academy of Sciences. Lundblad’s suit alleged that Verma made “overtly derogatory comments” about women. Furthermore, in reports going back to 1976, eight women alleged that Verma “grabbed their breasts, pinched their buttocks, forcibly kissed them, propositioned them, and repeatedly commented on their physical attributes in professional settings.”  “It was on everybody’s mouth that he was a harasser,” said molecular and cell biologist Monica Zoppè, who claimed she was forcibly kissed by Verma when she was a postdoctoral scientist in his lab.  Although Verma issued a statement to Nature that he had never used his position to take advantage of others, he resigned from the Salk earlier this year.

“Gender discrimination is everywhere,” says Christine Williams, a sociologist at the University of Texas at Austin. “But what makes the experience unique among scientists is their almost unflappable belief in objectivity and meritocracy.” To change the situation, some universities have become more transparent about salaries, promotions and funding.  In the United Kingdom, Athena SWAN (Scientific Women’s Academic Network) program collects information from over 140 institutions and rank them in terms of how well they attract and advance women. “There has been so much progress,” Nancy Hopkins, a molecular biologist at the Massachusetts Institute of Technology told Nature, “but the progress is uneven.”

(Amy Maxmen, Nature)

Vector-borne diseases

Dengue rates plummet in Australian city after release of modified mosquitoes

In 2016, there were over 2000 cases of dengue fever in Australia, reaching a 20-year high. The mosquito that spreads dengue, Aedes aegypti, can also carry the zika virus, and there were 59 confirmed cases of zika in Australia that same year.  When left untreated, dengue fever has a mortality rate of over 20%.  Since October 2014, researchers have been testing a new strategy to combat mosquito-borne diseases in Townsville, Australia.  Over many months, the researchers released around 4 million Aedes aegypti mosquitoes carrying a strain of the Wolbachia bacteria that blocks the transmission of dengue, zika and other disease-causing viruses.  Wolbachia are bacteria that can live inside insect cells, and are estimated to infect more than 60% of all insect species. One strain of Wolbachia is known to have the ability to halve the adult lifespan of Aedes aegypti and stimulate the mosquito’s immune system to make it more effective against disease causing viruses such as dengue. Wolbachia may also compete with disease causing viruses for the limited resources inside the mosquito.  According to the recently posted results in Gates Open Research, in the 44 months after the release of the mosquitoes, there were only 4 locally acquired dengue cases compared with 54 locally acquired cases over the 44 preceding months.  Similar studies with Wolbachia are ongoing in Yogyakarta, Indonesia, Rio de Janeiro, Brazil and Bello and Meddlin, Colombia, where dengue is a major health burden. Earlier this year, Wolbachia carrying Aedes aegypti mosquitoes were released in Vietnam and Pacific islands such as Fiji, Vanuatu and Kiribati.

(Ewen Callaway, Nature)

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August 10, 2018 at 1:22 pm

Science Policy Around the Web – August 3, 2018

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By: Cindo O. Nicholson, Ph.D.

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source: pixabay

Drug Control

D.C. has had more than 300 synthetic marijuana overdoses in 2 weeks

A synthetic marijuana (cannabinoids) known as K2 is suspected to be the cause of more than 300 overdoses in Washington D.C. What is happening in D.C. is a microcosm for what is occurring in multiple states across the country. Recently, the U.S. Food & Drug Administration (FDA) has posted a statement on reports of deaths and severe illnesses from the use of synthetic cannabinoids.

Synthetic cannabinoids are different from natural marijuana. Synthetic cannabinoids are designed to stimulate the same receptors stimulated by natural marijuana. However, the contents of synthetic cannabinoids are not consistent; each batch can differ in the concentrations of active ingredients and there are even variations within batches. Furthermore, there can be other toxic ingredients like brodifacoum which is a vitamin K antagonist and a compound used in rat poisons. It is believed that that brodifacoum is added to synthetic cannabinoids in order to extend the duration of euphoria or “high”. However, brodifacoum’s antagonism of vitamin K can cause severe bleeding.

The components and concentration of active ingredients in these synthetic products are not regulated, unlike drugs sold in the pharmacy. The FDA has worked with the Drug Enforcement Agency in the past to put several of these synthetic cannabinoids into Schedule I of the Controlled Substances Act. However, producers of these substances have counteracted these efforts by changing how they’re distributed and by changing the chemical structure of these substances just enough to circumvent state and federal requirements.

Consumers of synthetic marijuana need to be mindful that these drugs are not the same as natural marijuana, and the contents of these drugs could contain toxic substances like brodifacoum that can cause severe illness or death. While there are public health laboratories with the expertise to isolate and classify new ingredients that show up in these synthetic compounds, it is a challenge for law enforcement to make the new ingredient illegal on the sole basis that it fits into a class of chemicals that are hazardous to human health.

(Marisa Peñaloza, NPR)

Clinical Trials

Controversial US ketamine trial sparks ethics complaints

The consumer advocacy group Public Citizen has filed a complaint to the U.S. government because of two clinical studies where ketamine was administered to patients without their consent. Both clinical studies were conducted in Minneapolis, Minnesota by researchers at the Hennepin County Medical Center (HCMC). In both studies, agitated patients were administered either ketamine or another sedative by paramedics.

In the first study, the HCMC conducted a previous trial to compare the ketamine to the sedative haloperidol and found that the percentage of patients that developed respiratory issues requiring a breathing tube after ketamine administration (39%) was almost 10 times the percentage of patients administered haloperidol that needed a breathing tube (4%). These findings were published in the journal Clinical Toxicology.

In June 2017, the HCMC proceeded with a second clinical trial where the administration of ketamine to agitated patients was compared to the drug midazolam. This trial was halted in June 2018 when it was reported that Minneapolis police encouraged paramedics to use ketamine on troublesome patients, some of whom were already physically restrained. Many of these patients breathing and heart rate stopped and had to be resuscitated at the hospital. The HCMC released a statement on its website denying that paramedics involved in the study could be directed by the police in this manner. Furthermore, the hospital states that paramedics were instructed that using ketamine or another sedative on a patient has to be a medical decision.

The Food & Drug Administration (FDA) ethics guidance for clinical trials on occasion allows trials to proceed without patient consent if it is known that there is minimal risk to the patient (The 21st Century Cures Act, 2016). The HCMC found from their first study that patients sedated with ketamine had a greater risk of serious respiratory complications, but their Institutional Review Board (IRB, an internal ethics oversight body) allowed a second clinical trial without requiring patient consent. The HCMC has responded to Public Citizen’s complaints and intends to participate in both internal and independent reviews of their study.

(Sara Reardon, Nature)

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August 6, 2018 at 10:50 am